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The FDA’s Ban on Brominated Vegetable Oil: What F&B Manufacturers Need to Know

Silver Spring, MD, USA 11/10/2020: Exterior view of the headquarters of US Food and Drug Administration (FDA). This federal agency approves medications, vaccines and food additives for human use.

Key Takeaways:



The U.S. Food and Drug Administration (FDA) recently finalized a rule to
revoke the use of brominated vegetable oil (BVO) as a food additive, citing concerns over its potential health effects, particularly thyroid toxicity. The rule took effect on August 2, 2024, allowing one year for companies to reformulate, relabel, and discontinue sales of BVO-containing products. 

“After that year is up on August 2, 2025, I would expect the FDA to determine whether any companies are marketing products labeled as containing BVO,” said Michael Varrone, Counsel in Sidley’s Food, Drug, and Medical Device practice. “The agency could, for example, use databases to identify all products with BVO listed as an ingredient within the previous year, match those products to a sales database by UPC code, and then refer to ingredient listings on manufacturer websites.”

What are safer alternatives to BVO?

According to the FDA, only a few products still contain BVO, used for decades to stabilize flavoring oils in citrus-flavored beverages like sodas and sports drinks. BVO prevents these oils from separating and rising to the surface, maintaining a uniform appearance. 

Many companies have already been phasing out the use of BVO, substituting with other emulsifiers and stabilizers, including:

Whether these are suitable substitutes will depend on specific product requirements. Manufacturers should evaluate available options to ensure they meet formulation needs while maintaining product quality.

What challenges might companies face when reformulating products?

For manufacturers currently using BVOs, finding alternatives that maintain flavor and stability may prove complex and costly. Companies will need to prepare not only to meet compliance requirements, but communicate changes in a way that maintains customer loyalty. 

“Reformulating products comes with costs, including costs for turbidity tests, consumer focus groups, production scale-up testing, and relabeling,” Varrone explained. “Companies may have to spend more money in the short term to ensure that they have a reformulated product that complies with the law and is acceptable to their current customers.”

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